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| Name | Class |
|---|---|
| St. John's Research Institute | OTHER |
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This is a randomised, open-label; parallel group, multicentric study comparing the efficacy and safety of fixed-dose-combinations of Metoprolol XL plus Amlodipine with individual components of the combination. SelomaxTM50/5 will also be compared with SelomaxTM 25/2.5 in lowering of BP (SBP and DBP) in Indian patients with essential hypertension.Male and female patients of essential hypertension aged between 18-80 years will be studied. The patients should not have a history of prior cardiovascular disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | FDC of Metoprolol XL 50mg + Amlodipine 5mg |
|
| 2 | Experimental | FDC of Metoprolol XL 25mg + Amlodipine 2.5mg |
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| 3 | Active Comparator | Extended release Metoprolol succinate |
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| 4 | Active Comparator | Extended release Metoprolol succinate |
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| 5 | Active Comparator | Amlodipine 5mg in immediate release formulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metoprolol XL 50mg + Amlodipine 5mg | Drug | tablet,oral,OD,8 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in BP with Selomax™ 50/5 at the end of the randomisation treatment period. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in BP (SBP,DBP & mean BP) with SelomaxTM 25/2.5 at the end of the randomisation period. | 8 weeks | |
| Change in the heart rate,Number of responders & control rates. | 8 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Hyderabad | Andhra Pradesh | India | |||
| Research Site |
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| Metoprolol XL 25 mg + Amlodipine 2.5mg | Drug | tablet,oral,OD,8 weeks |
|
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| Metoprolol XL 50mg | Drug | tablet,oral,OD,8 weeks |
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| Metoprolol XL 25 mg | Drug | tablet,oral,OD,8 weeks |
|
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| Amlodipine 5mg | Drug | tablet,oral,OD,8 weeks |
|
|
| Incidence of adverse events (serious and non-serious) in each arm.Change in hemogram, serum chemistry (Liver function tests (LFT), Renal function tests (RFT), plasma lipids, Blood Glucose, HbA1c), and Ur.albumin |
| 8 weeks |
| Ahmedabad |
| Gujarat |
| India |
| Research Site | Bangalore | Karnataka | India |
| Research Site | Calicut | Kerala | India |
| Research Site | Mumbai | Maharashtra | India |
| Research Site | Pune | Maharashtra | India |
| Research Site | Delhi | National Capital Territory of Delhi | India |
| Research Site | Jaipur | Rajasthan | India |
| Research Site | Lucknow | Uttar Pradesh | India |
| Research Site | Kolkata | West Bengal | India |
| Research Site | Bangalore | India |
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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